ISBT Consistent Coding Systems
Harmonization of Standards for Medical Products of Human Origin
Medical Products of Human Origin (MPHO) comprise all human derived donated material used for human application and include blood, organs, bone marrow, cord blood, corneas, tissues, reproductive cells and milk. These products have much in common: they are derived from a consenting donor; they carry risks of disease transmission; they may be distributed globally; and they are of unique and often irreplaceable therapeutic value.
Safety of MPHO is enhanced by effective systems of traceability, transparency, vigilance and surveillance. The need to harmonize practice as recognized by WHA 57.18, to ensure continual improvement, and to effectively manage international distribution requires a global approach to governance of such systems, and this in turn requires a common language supported by standard terminology and consistent coding.
Consistent Coding Systems
The need for a globally standardized coding system has been recognized by the World Health Assembly Resolution in WHA63.22 which calls on Member States “to encourage the implementation of globally consistent coding systems for human cells, tissues and organs”.
Such a consistent coding system offers benefits in several important ways. Globally unique identification using standard machine readable formats supports rapid and accurate traceability. The ability to identify source organizations as part of the identification improves transparency and this in turn facilitates monitoring of ethical practice and safe procedures. Globally agreed product terminology provides a basis for gathering accurate activity data and provides a common platform for vigilance monitoring.
A single donor may, through their lifetime, donate many types of MPHO. Risks associated with the donor may require recall of all donated material and this demands a traceability solution that is effective across the full range of MPHO.
ISBT 128 harmonized coding system for all MPHO
A 2012 international transplantation workshop convened by WHO considered global traceability and recommended close collaboration between national health authorities and agencies and scientific and professional societies, with ICCBBA and WHO managing a global governance service for the coding and labelling of MPHOs.
ISBT 128, managed by ICCBBA, is the sole global standard for the identification and coding of MPHO. It supports global governance by providing a donation numbering system that ensures globally unique identification. It is built upon internationally agreed terminology published in the ISBT 128 Standard Terminology which is a publically available document.
WHO and ICCBBA have been pursuing a joint work program since 2011 in support of the objectives of WHA63.22.
Project SONG (Standardization of Organ Nomenclature Globally) was established by WHO in collaboration with ICCBBA, the international NGO responsible for the ISBT 128 Information Standard for Blood and Transplant. The First Expert Meeting took place in May 2011 and a draft nomenclature was developed. Following this meeting and a public consultation the nomenclature was further refined and the first version of the WHO Standard Nomenclature for organ transplants was developed.
WHO Bulletin article on ISBT 128
SONG Project report
WHO Standard Organ Transplant Nomenclature – version 1.0
- ISBT 128 Standard Terminology
- • Slaper-Cortenbach, Ineke; ISBT 128 coding and labeling for cellular therapy products. Cell and Tissue Banking (2010).
Ocular tissue terminology
Armitage, W. John; Ashford, Paul; Crow, Barbara; Dahl, Patricia; DeMatteo, Jennifer; Distler, Pat; Gopinathan, Usha; Madden, Peter W.; Mannis, Mark J.; Moffatt, S. Louise; Ponzin, Diego; Tan, Donald. Standard Terminology and Labeling of Ocular Tissue for Transplantation.
Cornea 32(6):725-728, June 2013.doi: 10.1097/ICO.0b013e3182873405